FRANKLIN, Mass., March 30 /PRNewswire-FirstCall/ -- PLC Systems Inc. , a company focused on innovative cardiac and vascular medical device-based technologies, today reported financial results for the three and twelve month periods ended December 31, 2009.
Mark R. Tauscher, president and chief executive officer of PLC Systems Inc., stated, "We are very pleased that the second investigator-sponsored clinical trial, REMEDIAL II, on our RenalGuard System(TM) produced consistent positive data with that of the first investigator-sponsored study of RenalGuard, the MYTHOS trial, conducted at the Centro Cardiologic Monzino-University of Milan in Milan, Italy. This provides more scientific evidence that RenalGuard is safe and effective at significantly reducing rates of Contrast-Induced Nephropathy (CIN) in at-risk patients. This new interim data, covering 123 patients enrolled at the Clinica Mediterranea in Naples, Italy, was presented at this year's Continuous Renal Replacement Therapies (CRRT) conference in San Diego, California in February, which was well attended by nephrologists from around the world, many of whom could be important influencers for future sales of this product."
During the fourth quarter of 2009 PLC shipped 250 single use RenalGuard disposable sets and six RenalGuard consoles internationally, compared to 235 single use RenalGuard disposable sets and no RenalGuard consoles that shipped in the fourth quarter of 2008.
PLC recorded one TMR laser shipment during the fourth quarter of 2009, compared to no TMR laser shipments during the fourth quarter of 2008.
The REMEDIAL II trial is a randomized, open-label controlled clinical trial ongoing at the Clinica Mediterranea in Naples, Italy, under the leadership of Dr. Carlo Briguori, a world-renowned CIN prevention specialist. The interim results, reported on the first 123 patients, were presented in a poster at the CRRT conference by Dr. Richard Solomon, Professor of Medicine at the University of Vermont College of Medicine and a member of PLC's Scientific Advisory Board. The data showed a 3.2% CIN rate in the RenalGuard treated group compared to a 13% CIN rate in the control group (using the same definition for CIN as that which was used and results reported on in the MYTHOS trial). This trial is expected to continue through 2010. As announced in February, in interim data based upon 114 patients from the MYTHOS trial, in the RenalGuard treated group, the incidence rate of CIN was only 3.7%, 75% lower than the 15% CIN rate recorded in the control group. The RenalGuard treated group also experienced a statistically significant fewer number of in-hospital major adverse events.
PLC has also announced today that it has expanded RenalGuard's distribution in the European Union to Austria, having signed a distribution agreement with Zodl Medical. In addition, the company signed a distribution agreement with Koru Medical for New Zealand and Dispomed Promet for Croatia. In February, PLC announced that it had signed distribution agreements covering Russia, Belgium, the Netherlands and Luxembourg and all of the former Soviet Socialist Republic nations; Portugal; China and Taiwan, as well as Italy, Spain, Monaco, Pakistan and Bangladesh.
For the twelve months ended December 31, 2009, total revenues were $4,711,000, compared to $5,330,000 in 2008. The net loss for 2009 was $1,626,000, or $0.05 per basic and diluted share, compared to a net loss of $1,940,000, or $0.06 per basic and diluted share, in 2008.
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About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device. Additional company information can be found at www.plcmed.com.
PLC Systems, PLC Medical Systems, PLC, CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
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PLC Systems
